Scope Biosciences B.V. has announced that eazySNP C. auris FKS1 S639, a CRISPR-based test developed with AmplexDiagnostics GmbH, is now CE marked under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR). Scope Biosciences, the Wageningen University spinoff, based in Wageningen, the Netherlands, says the test uses the company’s technology to detect mutations associated with antifungal resistance, and marks the platform’s entry into regulated human diagnostics.

Detecting echinocandin resistance

The assay detects mutations associated with resistance to echinocandins in Candida auris, a yeast that can cause severe infections and can be life threatening. According to the company, echinocandins are the recommended initial treatment for most C. auris infections but are ineffective against the mutant, which does respond to alternative antifungal treatment. The test runs from a yeast colony on AmplexDiagnostics’ eazyMini instrument and delivers a result in approximately 45 minutes.

Single-nucleotide discrimination

Scope’s platform combines isothermal DNA amplification with CRISPR detection to distinguish genetic sequences that differ by a single nucleotide. With eazySNP, that capability is incorporated into a clinical test on an existing diagnostic instrument, bringing the company’s scopeDx® technology into human diagnostics.

“For Scope, eazySNP is an important step in that our proprietary CRISPR type III technology is now part of a CE marked clinical test,” said Bas van der Baan, chief executive officer of Scope Biosciences. “Working with Amplex shows how we can bring our detection technology into products with an established diagnostics manufacturer. We see further opportunities to work with partners on tests where simplicity, speed and molecular precision matter.”

From crop pathogens to human health

Scope already applies its platform to on-site crop pathogen detection, with tests used by seed producers including Syngenta, KWS and Bejo. The collaboration with AmplexDiagnostics, which has developed and supplied molecular in vitro diagnostics since 2002, extends the platform’s applications into human health. It combines Scope’s detection technology with Amplex’s expertise in clinical diagnostics and regulatory requirements.

For more information, visit: www.scopebio.com
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